Submit data in electronic common technical document (eCTD) format

Make sure you are familiar with eCTD terminology. Read Glossary of terms for electronic Common Technical Document (eCTD).

You'll need a TGA Business Services client account. See TGA Business Services: getting started with the TGA.

What you need

You need an e-ID (electronic identifier) from us if you plan to submit data in eCTD format.

You must request an e-ID for each active agent you plan on submitting data for. You don’t need a separate e-ID for each different strength and dosage form.

You don't need a new e-ID if moving from NeeS (Non-eCTD electronic Submission) to eCTD.

Request an e-ID

To request an e-ID, send an email to eSubmissions@health.gov.au with:

• the applicant's name as listed in their client account
• the name of the active ingredient
• a description of the submission (e.g. application type or dosage form).

For a master file, include:

• the subject of the eCTD sequence
• the name and address of the manufacturing site.

Use the following supplementary materials to help you prepare your sequence:

• regulatory requirements for your therapeutic good and application type outlined in

Cover letter

Your cover letter must include:

• in the subject line:
  - e-ID
  - sequence number
  - related sequence number (consistent with the XML envelope)
• description of the submission, including:
  - type and number of electronic media
  - approximate submission size
  - any characteristic concerning the media we need to know
• description of the software used to check the files for viruses
  - statement confirming the submission is virus-free
• regulatory and IT contacts for the submission
• validation tool and version used
• address and justify any validation warnings (if submitting in NeeS)
• paper copy of the cover letter (if the sequence was transferred through physical media).

Compile

You must populate your XML envelope before you start compiling.

Make sure the information within the envelope is accurate and complete. Errors can lead to delays in processing your sequence. To find out how to create the envelope, see eCTD specifications.

To submit in eCTD format, you need eCTD software. This enables you to compile and publish your data. You should configure the software with the latest version of the TGA eCTD specification.

Do not make any changes to your sequence once it's published. Changes can lead to validation errors and delays in processing.

You should compile and publish your sequence with support from your eCTD software vendor or consultant.

Validate

We will not accept sequences with errors. If there are errors, you will need to resolve them and re-submit.

You must:

• validate your sequence before sending it to us.
• eliminate validation warnings wherever possible.
• If you cannot eliminate all validation warnings, you must address and justify them.

For information on eCTD validation findings and severity levels, see Validation Result

You should use eCTD software which:

• supports current and ongoing TGA eCTD Module 1 requirements
• will minimise the possibility of technical validation errors

We do not recommend any particular software to prepare and validate eCTD submissions.

If you have any concerns about your sequence validation, email eSubmissions@health.gov.au.

Provide your sequence as follows:

• single zipped file, containing an e-ID folder, and a sequence subfolder within that which contains the new sequence data. (e.g. e123456.zip -> e123456/0001).

Submissions under 20MB

Send via email to eSubmissions@health.gov.au.

Include the following information in the title:

• e-ID
• sequence number
• submission number

Include the following information in the body of the email:

• the type of application
• whether it is an initial data set or a response

Do not send sequences to individual evaluators.

Submissions over 20MB

Send via the online portal.

Include the following information in the title:

• e-ID
• sequence number
• submission number

Email eSubmissions@health.gov.au to request access to the portal.

Send via post

Send on one of the following non-returnable media:

• USB
• non-rewritable CD
• DVD (do not use double-sided discs)

Ensure your media is not password locked.

Postal address

Dossiers (type of therapeutic good)

Records Management

Therapeutic Goods Administration

PO Box 100

Woden ACT 2606

Australia

Courier (street address)

Dossiers (type of therapeutic good)

Records Management

Therapeutic Goods Administration

27 Scherger Drive

Fairbairn ACT 2609

Australia

Your sequence will be automatically validated once we receive it.

We will email the result to the address you have nominated. It is the responsibility of the contacts you nominate to take any required actions in the validation report.

No validation errors or warnings

Your sequence was successfully uploaded.

Validation warnings

Your sequence was successfully uploaded. You will be a sent a copy of the validation report.

Validation errors

Your sequence was not successfully uploaded. You will be sent a copy of the validation report.

Compile an electronic Common Technical Document (eCTD) baseline sequence.

Withdraw information from your electronic Common Technical Document (eCTD) submission.

Transfer ownership of your electronic Common Technical Document (eCTD) dossier.

Submit data in Non-eCTD electronic Submission (NeeS) format.

For help submitting a sequence, email eSubmissions@health.gov.au.

For help with eCTD specifications, email EDR@health.gov.au.